Executive -QA

Lupin Ltd; Sikkim; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Lupin Ltd in India seeks a QA/compliance professional with 6-9 years of experience in pharmaceutical manufacturing. The role focuses on batch records, SOP and cGMP compliance on the shop floor, line clearance, and in-process checks across multiple products.

Responsibilities include sampling, SAP record reviews, APQR preparation, CAPA handling, self-inspections, and training technicians on cGMP. Batch release participation is also required.

Qualifications

• Graduation in Pharmacy is required.
• 6–9 years work experience in QA/compliance roles.

Responsibilities

• Compliance to batch records and cGMP requirements on the shop floor.
• Ensuring SOPs are followed and cGMP compliance.
• Line clearance and monitoring processes to prevent contamination.
• In-process checks at different manufacturing stages.
• Sampling as required during manufacturing stages.
• Stage-wise review of batch records to enable timely release.
• Process validation, cleaning validation/verifications (APQR input).
• Review of batch/packing records in SAP; IPQA participation.
• CAPA, change controls, OOS/OOT, investigations via QAMS.
• Self-inspection coordination and observation compilation.
• Training technicians on cGMP and SOPs; batch release participation.
• eDMS activities and ongoing IPQA participation.

Job description

Job Description

Compliance to the instructions given in Batch records of various products.

Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.

Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

“Sampling” at different stage of manufacturing or as per the requirement.

Stage wise review of batch records and compliances if any, to facilitate timely release.

Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

Review of master batch manufacturing record and batch packing record in SAP

Active participation in execution of Qualification and calibration activity.

Periodic review and preparation of APQR.

Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.

Co-ordination & execution of Self Inspection and compilation of self-inspection observations.

Active participation in investigation related to product / system failure.

Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

Active Participation in Batch Release Activity.

Handling eDMS activities.

Active participations in all the IPQA activities.

Work Experience

6-9 years

Education

Graduation in Pharmacy

Competencies

Job Description

Compliance to the instructions given in Batch records of various products.

Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.

Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

“Sampling” at different stage of manufacturing or as per the requirement.

Stage wise review of batch records and compliances if any, to facilitate timely release.

Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

Review of master batch manufacturing record and batch packing record in SAP

Active participation in execution of Qualification and calibration activity.

Periodic review and preparation of APQR.

Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS.

Co-ordination & execution of Self Inspection and compilation of self-inspection observations.

Active participation in investigation related to product / system failure.

Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

Active Participation in Batch Release Activity.

Handling eDMS activities.

Active participations in all the IPQA activities.

Work Experience

6-9 years

Education

Graduation in Pharmacy

Competencies